TEC4Home Heart Failure: Using Home Health Monitoring to Support the Transition of Care

NCT ID: NCT03439384

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-12-31

Brief Summary

TEC4Home Heart Failure is a randomized controlled trial (RCT) that examines how home health monitoring (HHM) can support Heart Failure (HF) patients during the transition of care from hospital to home. The HHM solution includes a weight scale, blood pressure cuff, pulse oximeter and tablet computer, which patients use daily for 60 days to record these metrics and answer questions on their symptoms. This data is sent to a nurse who is able to monitor the patient's condition remotely. The hypothesis is that the TEC4Home HHM solution will be a cost-effective strategy to decrease 90-day Emergency Department (ED) revisits and hospital admission rates, and improve quality of life and self-management for patients living with Heart Failure.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental: Home Telemonitoring

Patients will receive home telemonitoring equipment and monitor their health for 60 days post-enrollment. A monitoring nurse will receive and review the patients health data on a daily basis for the 60 day duration and provide remote care, counseling and education.

Group Type: EXPERIMENTAL

Home Telemonitoring

Intervention Type: DEVICE

Patients will monitor their weight, blood pressure, oxygen saturation and symptoms with sensors and a tablet computer provided to them. Patients are asked to do this everyday for 60-days. A monitoring nurse will be receiving the data electronically and reviewing on a daily basis.

Control: No Home Telemonitoring

The patient will not receive any home telemonitoring once enrolled and will continue to receive the usual care he/she can expect as part of his/her care plan.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Home Telemonitoring

Patients will monitor their weight, blood pressure, oxygen saturation and symptoms with sensors and a tablet computer provided to them. Patients are asked to do this everyday for 60-days. A monitoring nurse will be receiving the data electronically and reviewing on a daily basis.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Be 19 years of age or older (age of majority in British Columbia)
• Have one or more typical symptoms of Heart Failure (i.e. dyspnoea at rest or minimal exertion (includes orthopnoea, reduced exercise tolerance)) AND
• Have one or more typical signs of Heart Failure (i.e. elevated jugular venous pressure, pulmonary crepitations, pleural effusions, peripheral oedema) AND
• Have one or more objective measures of heart failure:
• Radiological congestion.
• Elevated BNP ≥ 400 pg/mL or NT-proBNP ≥ 1000 pg/mL.
• Reduced left ventricular ejection fraction <40% (or <45%) in previous 12 months.
• Diastolic dysfunction including tissue Doppler E/e' ratio > 15 in previous 12 months.
• Pulmonary capillary wedge pressure >20 mmHg.
• Diuretic therapy. The additional value of diuretic therapy (IV or oral) is debatable, as presumably unlikely (or unsafe) that patient with genuine HF will be discharged without diuretic.

Exclusion Criteria

• Physical barriers e.g. unable to stand on scales.
• Cognitive impairment (e.g. MMSE <20), unless suitable caregiver support.
• Language (must be able to read and understand English), unless suitable caregiver support.
• Documented history of current and active substance misuse (within 3 months).
• Lack digital connectivity or landline phone connection.
• No regular care provider e.g. GP, or at least regular walk-in clinic.
• Existing intensive system of care: LVAD, transplant, dialysis.
• Anticipated improvement due to revascularization (PCI/CABG) or valve intervention during index hospitalization.
• Anticipated survival <90 days. Active palliative care, less-than level III care, disseminated malignancy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Kendall Ho

Lead, Digital Emergency Medicine; Professor, Department of Emergency Medicine, Faculty of Medicine, UBC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kendall Ho, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

UBC

Vancouver, British Columbia, Canada

Countries

Canada

References

Ho K, Novak Lauscher H, Cordeiro J, Hawkins N, Scheuermeyer F, Mitton C, Wong H, McGavin C, Ross D, Apantaku G, Karim ME, Bhullar A, Abu-Laban R, Nixon S, Smith T. Testing the Feasibility of Sensor-Based Home Health Monitoring (TEC4Home) to Support the Convalescence of Patients With Heart Failure: Pre-Post Study. JMIR Form Res. 2021 Jun 3;5(6):e24509. doi: 10.2196/24509.

Reference Type: DERIVED

PMID: 34081015 (View on PubMed)

Other Identifiers

H17-02846

Identifier Type: -

Identifier Source: org_study_id